Tissue Samples and Bodily Fluid Specimens Banking

Endocrine Disorders of Female Reproductive System Clinical Trial

Official title:

Tissue and Bodily Fluid Specimens From Women Presenting to the Reproductive Endocrinology Clinic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02431884
• Other study ID #: 11-01629-XP
• Status: Completed
• Start date: January 2012
• Est. completion date: March 25, 2020

Study information

• Verified date: November 2020
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to collect a portion of blood/tissue specimens that will be generated during the participants office visit or surgery. The investigators are asking whether a small portion of the specimen/s could be set aside and banked for future research purposes. Data originating from participants will be gathered and analyzed in research studies that will help understanding various medical conditions such as polycystic ovary syndrome (PCOS), congenital uterine malformations, endocrine malfunctions, endometriosis, and infertility.

Description:

PURPOSE: Women present to the Reproductive Endocrinology clinic with different concerns. These may involve conditions such as pelvic pain, endometriosis, Mullerian anomalies, polycystic ovary syndrome, abnormal uterine bleeding, menopausal symptoms, or infertility. Understanding the meaning of different biologic markers in their blood serum or tissues could help advancing the medical knowledge in the different conditions.

RATIONALE: To understand the meaning of different biologic markers in the patients' blood serum or tissue samples.

POPULATION: Patients identified among all women presenting to the reproductive endocrinology clinic.

Patients may undergo endometrial biopsy or surgery to evaluate their condition. In these instances, the investigators will ask the patients whether a small portion of their specimen/s could be collected and banked for future research purposes.

DESIGN: Prospective blood/tissue collection.

PROCEDURES: A small portion of the patient's blood or tissue specimen collected at the time of a medically indicated blood draw or surgical procedure will be collected and banked for future research purposes. Sample collection will be performed on existing specimens, once the specimens have been obtained for medical indications. No additional procedures will be performed on the patients for research purposes only.

OUTCOME MEASURES: Creation of a blood serum/tissue specimens bank for future clinical research studies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 25, 2020
• Est. primary completion date: March 25, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

• females of childbearing potential experiencing reproductive endocrinology related problems.

Exclusion Criteria:

• male or female not of childbearing potential

Related Conditions & MeSH terms

• Endocrine Disorders of Female Reproductive System
• Endocrine System Diseases

Intervention

Procedure:
• collect body fluids/tissues & med history
collect tissues/fluids & history

Locations

Country	Name	City	State
United States	Regional One Health Ob-Gyn Clinic	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specimen bank for future clinical research studies	Creation of a blood serum/tissue specimens bank for future clinical research studies.	The samples collected during the clinical visit will be preserved and maintained as frozen specimens until the research is performed, which may occur from: within 1 year, and up to 24 years after collection.